Clonazepam

Product NDC: 71610-852
Requested package NDC: 71610-852-30
11-digit product format: 716100852
Labeler code: 71610
Product ID: 71610-852_20b33aac-b9ba-2743-e063-6294a90ae043
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clonazepam
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075150
Marketing category: ANDA
Marketing start: 2023-01-17
Substance: CLONAZEPAM
Active strength: 1 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075150-001	CLONAZEPAM	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05
A075150-002	CLONAZEPAM	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05
A075150-003	CLONAZEPAM	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A075150-001	AB
A075150-002	AB
A075150-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-002	CLONAZEPAM	1MG	TABLET / ORAL	AB	1998-10-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-003	CLONAZEPAM	2MG	TABLET / ORAL	AB	1998-10-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-001	CLONAZEPAM	0.5MG	TABLET / ORAL	AB	1998-10-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 87 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075150-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075150-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075150-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075150-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075150-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075150-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075150-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075150-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075150-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075150-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075150-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075150-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075150-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075150-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075150-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075150-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075150-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075150-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075150-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075150-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Clonazepam
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLONAZEPAM	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5PE9FDE8GB	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197528	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
20b3125e-4489-3c53-e063-6294a90a6539	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f8e2a02d-e7b1-29aa-eb39-98a679441d91	Product name	3	20190927
dc4336d1-53d4-d410-38d3-71aa2ce4749b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71610-852-12	Clonazepam	12 in 1 BOTTLE	TABLET	12	1
71610-852-15	Clonazepam	15 in 1 BOTTLE	TABLET	15	1
71610-852-28	Clonazepam	28 in 1 BOTTLE	TABLET	28	1
71610-852-30	Clonazepam	30 in 1 BOTTLE	TABLET	30	1
71610-852-45	Clonazepam	45 in 1 BOTTLE	TABLET	45	1
71610-852-46	Clonazepam	56 in 1 BOTTLE	TABLET	56	1
71610-852-53	Clonazepam	60 in 1 BOTTLE	TABLET	60	1
71610-852-60	Clonazepam	90 in 1 BOTTLE	TABLET	90	1
71610-852-80	Clonazepam	180 in 1 BOTTLE	TABLET	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-852-12	EA - Each	71610-852	4eed5a5f-6c8a-4934-8d29-7fbfe59b9881	1	2024-10-04
71610-852-15	EA - Each	71610-852	145573fe-970e-471c-82d8-b774725950f9	1	2024-10-04
71610-852-28	EA - Each	71610-852	c8e360f2-1be4-4877-bc10-0b10e1e822ad	1	2024-10-04
71610-852-30	EA - Each	71610-852	2fe74271-f7c2-4dd6-a914-155ea223a579	1	2024-10-04
71610-852-45	EA - Each	71610-852	ec6b5453-5375-41f3-8c44-83443d9ea5ce	1	2024-10-04
71610-852-46	EA - Each	71610-852	b598d8bf-fd46-40ae-b827-18be30a2a84b	1	2024-10-04
71610-852-53	EA - Each	71610-852	25bec7f0-a23e-49db-aa70-6e979b092e21	1	2024-10-04
71610-852-60	EA - Each	71610-852	44147e19-3771-4fc0-a2c7-82a9b22e6021	1	2024-10-04
71610-852-80	EA - Each	71610-852	c4b8a4eb-13c9-4746-bc55-ae466c8e58ae	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-852	CLONAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	1	Current NDC, 9 package rows	20240831_20b3125e-4489-3c53-e063-6294a90a6539.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	2606ecf9-3d71-4c1c-bfda-d7d98ffc6011	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	1fb0807c-dccd-47a5-ada4-91418c4f47f5	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	REMEDYREPACK INC.	f613573a-3e8b-4abf-af69-0268f3d6f481	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Proficient Rx LP	44f39aa8-a7bc-4e42-977c-31583e6388ae	2026-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Bryant Ranch Prepack	dec8b5b2-2490-4880-a8d1-707b57954297	2025-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	214e760b-c909-bd93-e063-6294a90ae74a	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Aphena Pharma Solutions - Tennessee, LLC	20b3125e-4489-3c53-e063-6294a90a6539	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150 ndc (package): 71610-852-30 ndc (product): 71610-852 ndc11 (package): 71610085230
Clonazepam	CLONAZEPAM	Advanced Rx Pharmacy of Tennessee, LLC	04db0fbe-7fa3-28af-e063-6294a90abbe6	2024-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150
Clonazepam	CLONAZEPAM	Aurobindo Pharma Limited	b1582eb7-af35-45d5-a52e-0e380d08527d	2023-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075150 application number: ANDA075150

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5PE9FDE8GB	CLONAZEPAM	1622-61-3	CLONAZEPAM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197528	clonazePAM 1 MG Oral Tablet	PSN	20b3125e-4489-3c53-e063-6294a90a6539	1
197528	clonazepam 1 MG Oral Tablet	SCD	20b3125e-4489-3c53-e063-6294a90a6539	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-852-30	71610085230	30 TABLET in 1 BOTTLE (71610-852-30)	30 tablet	2024-08-27	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clonazepam Tablets, USP CIV 0.5 mg, 1 mg and 2 mg Rx only	Aphena Pharma Solutions - Tennessee, LLC	2024-08-27	HUMAN PRESCRIPTION DRUG LABEL	1